A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM)

Phase 1/2 Completed 50 enrolled Millennium Pharmaceuticals, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety and tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of TAK-079 monotherapy and when combined with a backbone regimen of pomalidomide and dexamethasone (PomDex) in Phase 1, and to provide a preliminary evaluation of the clinical activity of TAK-079 monotherapy in Phase 2a in participants with r/r MM.

Timeline

Start: 2018-04-20
Primary completion: 2022-01-28
Completion: 2022-01-28

Publications

Krishnan AY, Patel KK, Mohan M, Jagannath S, Niesvizky R, Silbermann RW, Yu Z, Long T, McDonnell SRP, Berg D, Stockerl-Goldstein KE. Phase 1b study of the anti-CD38 antibody mezagitamab in patients with relapsed/refractory multiple myeloma. Blood Neoplasia. 2024 Sep 18;1(4):100043. doi: 10.1016/j.bneo.2024.100043. eCollection 2024 Dec.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mezagitamab	Monoclonal antibody	45 mg	Subcutaneous
Subject	Mezagitamab	Monoclonal antibody	135 mg	Subcutaneous
Subject	Mezagitamab	Monoclonal antibody	300 mg	Subcutaneous
Subject	Mezagitamab	Monoclonal antibody	600 mg	Subcutaneous
Subject	Mezagitamab	Monoclonal antibody	1200 mg	Subcutaneous
Background	Dexamethasone	Small molecule	—	Oral
Background	Pomalidomide	Other / unclassified	—	Oral

A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM)

Summary

Timeline

Publications

Drugs

Indications